Predictive Factors for Hypotensive Bradycardic Events During Arthroscopic Shoulder Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JongHae Kim, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier:
NCT01926561
First received: August 14, 2013
Last updated: October 7, 2013
Last verified: October 2013

August 14, 2013
October 7, 2013
August 2011
June 2012   (final data collection date for primary outcome measure)
Patient's age and gender, fasting time, administered volume, blood pressure, and heart rate variability [ Time Frame: Prior to ISBPB ] [ Designated as safety issue: No ]
Patients'age and gender, preoperative fasting time and volume of fluid administered, pre-block mean arterial pressure and heart rate, logarithmically transformed low frequency, high frequency, and total power of heart rate variability
Same as current
Complete list of historical versions of study NCT01926561 on ClinicalTrials.gov Archive Site
  • Side of the block, volume of local anesthetics used, number of patients having Horner's syndrome, hoarseness, and subjective dyspnea, degree of dermatomal and motor blockade [ Time Frame: 20 minutes after the end of local anethetics injection ] [ Designated as safety issue: No ]
    Side of the block, volume of local anesthetics used, number of patients having Horner's syndrome (ptosis, miosis, and anhidrosis), hoarseness, and subjective dyspnea, degree of dermatomal blockade (C5, C6, C7, C8, and T1), and degree of motor blockade (median, ulnar, radial, and musculocutaneous nerve)
  • Waiting time for sitting position, heart rate variability, mean arterial pressure, heart rate, frequency of antihypertensives and opioids use, and onset of hypotensive bradycardic events [ Time Frame: after the sitting position (expected average of 2 hours including surgery readiness time and duration of surgery) ] [ Designated as safety issue: No ]
    Waiting time for sitting position (time from the end of interscalene brachial plexus block to the sitting position), logarithmically transformed high frequency, low frequency, and total power of heart rate variability, mean arterial pressure, heart rate, frequency of intraoperative use of antihypertensives and opioids, and onset of hypotensive bradycardic events
Same as current
Not Provided
Not Provided
 
Predictive Factors for Hypotensive Bradycardic Events During Arthroscopic Shoulder Surgery
Predicting the Occurence of Hypotensive Bradycardic Events in the Patients Undergoing Arthroscopic Shoulder Surgery in the Sitting Position Under Interscalene Brachial Plexus Block

Patients's demographics and perioperative factors affect the occurrence of hypotensive bradycardic events in the patients undergoing arthroscopic shoulder surgery in the sitting position under interscalene block.

Patients' age, Side of the block,Horner's syndrome, the degree of blockade, preoperative fasting time and fluid administration volume, waiting time for sitting position after the block, intraoperative use of opioids and antihypertensives, and change of heart rate variability before the block and after sitting position affect the occurrence of hypotensive bradycardic events in the patients undergoing arthroscopic shoulder surgery in the sitting position under interscalene block.

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients who are scheduled to receive elective shoulder arthroscopic surgery in the sitting position under interscalene brachial plexus block

Syncope, Vasovagal
Other: Interscalene brachial plexus block
After sterile draping around interscalene groove with povidone, a nerve stimulating needle connected to a nerve stimulator is inserted through the interscalene groove. Following involuntary contraction of shoulder, arm, forearm, or hand muscles with 0.5 milliamperes at 1 Hz using the nerve stimulator, 30 to 40 ml of mixture of 1% mepivacaine 20 ml and 0.75% ropivacaine 20 ml are injected.
Hypotensive bradycardic event
The participants are assigned to hypotensive bradycardic event (HBE) group when they experience signs or symptoms associated with syncope, hypotension, or bradycardia, which are treated with vasopressors or inotropics following sitting position after interscalene brachial plexus block is done. Otherwise, they are assigned to non-HBE group.
Intervention: Other: Interscalene brachial plexus block

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 15 and 80 years
  • American Society of Anesthesiologists physical status I-II
  • Body mass index < 35 kg/m2

Exclusion Criteria:

  • Coagulation deficiencies
  • Known allergies to local anesthetics
  • Neurologic deficit on the side to be operated
  • Inflammation at the puncture site for interscalene brachial plexus block
  • Coronary artery disease
  • Cardiac conduction disorders and arrhythmias
  • Congestive heart disease
  • Diabetes mellitus
  • Serum electrolyte abnormalities
  • Autonomic dysfunction
  • Psychiatric disorders
  • Patients refusal
  • Communications difficulties
  • Failure of interscalene brachial plexus block
Both
15 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01926561
CR-11-072
No
JongHae Kim, Daegu Catholic University Medical Center
Daegu Catholic University Medical Center
Not Provided
Study Chair: WoonSeok Roh, Doctor Daegu Catholic University Medical Center
Daegu Catholic University Medical Center
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP